Study Start Up Specialist - Senior - Spain - FSP

Parexel; United States; Vor Ort; USD 68.000 - 101.000; Vollzeit

Zusammenfassung

Parexel is seeking a Senior Study Start-up Specialist to operate in a country-level capacity, following project requirements and local regulations with minimal oversight. The role may include mentoring SSU Specialists and coordinating regulatory and contract activities for sponsor-driven trials.

The candidate should have extensive regulatory and start-up experience, strong knowledge of GCP, and the ability to work independently in a fast-paced environment.

Qualifikationen

• Bachelor’s degree or equivalent; 3–5 years in regulatory & start-up.
• Pharmaceutical or related industry experience.
• Experience in Start-up teams and in-house trials/process design.
• Excellent knowledge of GCP and regulations.
• Ability to mentor, lead and motivate junior staff.
• Ability to work independently in a fast-paced environment.

Aufgaben

• Coordinate site feasibility collation and tracking.
• Ensure CDA is in place for submissions.
• Manage regulatory/CA/EC submission information in CTIS and related systems.
• Prepare and submit regulatory packets and site contracts.
• Liaise with regulatory and legal teams to authorize documents.
• Maintain Trial Master File documentation (TMF).
• Support start-up planning and essential document checklists.

Kenntnisse

Regulatory start-up

GCP knowledge

Independent work

Problem solving

Mentoring

Pharmaceutical industry experience

Ausbildung

Bachelor's degree

Regulatory start-up experience 3–5 years

Jobbeschreibung

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at SSU Specialist Senior, home-based and sponsor dedicated, in Spain.

The Senior Study Start-up Specialist is responsible for quality deliverables at the country level; follows project requirements and applicable country rules, with minimal oversight from the SSU Manager and contributes to change initiatives across the SSU department. May have Line management/mentoring responsibilities for SSU Specialist.

We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.

As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects.

The most significant aspect of this position is

• Collation and tracking of site feasibility.
• Responsible for ensuring CDA is in place.
• Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information within JVRIM/CTIS, and similar information for other related organizations, for the assigned country eg IRAS
• Responsible for ensuring clinical trial insurance is in place for submission.
• Responsible for the translation and co-ordination of translations for documents required for submission.
• Creation, review, and customization of country/site specific Informed Consent Forms (ICFs)
• Works with regulatory team members and SSU Lead to secure authorization of regulatory documents.
• Works with legal, contract vendor and SSU Lead to secure authorization of contracts.
• Collects and reviews initial regulatory packets and site contracts for investigator sites.
• Coordinate efforts for all site activation related activities including but not limited to obtaining and maintaining regulatory and ethics approvals, review, and approval of essential documents for IP Release
• Prepares ongoing submissions, amendments, and periodic notifications required by central and local IRB/EC, CA, and other local regulatory authorities as needed within the country. Including safety notifications as required by local laws/guidelines.
• Ensures all relevant documents are submitted to the Trial Master File (TMF)
• Responsible for liaising with local CRA/CTM, Contract Vendor, and Regulatory Lead to enable a rapid clinical trial start up.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Attend project meetings with cross functional department leads to provide updates.
• Identify site issues (risks) during start-up process; resolve minor to moderate issues independently; escalator and participate in the resolution of complex issues.
• Escalate risks (e.g. timelines, etc.) to SSU Lead or CTM, as appropriate.
• Reviews and provide feedback to SSU Lead on site performance metrics.
• Maintains and manages SSU data tracking entries, reviews for completeness and accuracy.
• Facilitates process improvement efforts both within the department and in cooperation with other departments.
• Support the creation and development of start-up plans and essential document checklists.

From you we expect

• Bachelor’s Degree or 3 -5 years’ relevant experience, including 2 years of regulatory & study-start up experience or other relevant experience; or equivalent combination of education, training, and experience.
• Pharmaceutical or related industry experience
• Previous experience of working in a Start-up team,
• Experience of in-house trials/process design
• Excellent knowledge of GCP and regulations
• Contribute to training within SSU and update SOPs/WI
• Ability to work independently in a fast-paced environment.
• Strong problem-solving skills
• Ability to mentor, lead and motivate more junior staff